FDA Adverse Event
Malfunction
Summary report: N
ACRYSOF TORIC
MDR report key: 1191513
·
Received September 26, 2008
Report
- Report Number
- 1119421-2008-00753
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Report Date
- August 28, 2008
- Manufacturer
- ALCON RESEARCH, LTD/HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 08/29/2008 AND 09/19/2008 BY MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 09/16/2008.
Description of Event or Problem · 1
A SURGICAL TECH REPORTS THAT THE SURGEON FELT THE INTRAOCULAR LENS (IOL) WAS "OVERHANDLED" DURING THE LOADING PROCESS. THE IOL WAS NOT USED ON THE PATIENT AND THERE WAS NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF TORIC | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LTD/HUNTINGTON | SN60T4 | 10808387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |